There is an increasing awareness of the requirement to protect children from inadvertently gaining access to medications, especially prescribed medications. Sometimes, ingestion of only one or two pills of certain prescribed medications may prove fatal to a child. Moreover, there is an increasing awareness of the necessity to provide containers for prescribed medications which may otherwise may be readily and easily opened by an adult--that is, any person having the cognitive ability to understand the instructions for opening a pill container which requires certain manipulation and manual dexterity. Such persons are assumed, as well, to have the ability to understand that opening a pill container to gain access to the prescribed medication therein is a deliberate action, and is only undertaken when there is a necessity to attain access to the prescribed medication in the pill container.
It is also recognized that an adult person, as described above, may have sufficient manual dexterity to open a pill container, especially prior art pill containers as discussed hereafter, but may suffer from a debilitating condition such as arthritis. Such persons may generally be more elderly than the general population but, because of their living arrangement or perhaps the continuing expectation of visits by active and curious grandchildren, they may instruct their pharmacist to dispense their prescribed medications in pill containers that require specific manipulation and manual dexterity, but with lesser physical effort, but which are still child-resistant. The present invention will accommodate those criteria, unlike prior art pill containers.
Moreover, there is an increasing awareness that patients who receive a pill container of prescribed medications may wish to be assured in their own minds that the pill container has not been tampered with in the interval between when the dispensing pharmacist closed the container and when the container was delivered to the patient or a caregiver looking after the patient. The present invention provides a means for determining whether a container having prescribed medications therein has been tampered with after it was sealed by the dispensing pharmacist.
There are several well-known, so-called, child-proof or child-resistant pill containers in the market, and which are generally employed by dispensing pharmacists for using in filling prescriptions, where the prescription requires that the pharmacist dispense one or more of a plurality of pills, tablets, gel-caps, capsules, or the like. They include the so-called "push-and-turn" closures for pill containers, or "arrow-alignment" closures for pill containers. In both cases, the pill containers are of the standard cylindrical variety.
The push-and-turn system for pill containers requires that the closure or cap for the pill container be pushed axially downwardly and rotated at the same time. Sometimes, very considerable force is required; sometimes the force which is required is beyond that which can easily be exerted by arthritic patients, for example. Moreover, it has been observed that the specific force required between two otherwise identical closures and pill containers, each employing the push-and-turn system, may be different from one to the other.
The arrow-alignment system for pill containers requires relatively good eyesight in order to align an arrow on the closure or cap with an arrow which is usually embossed on the pill container. Even when the arrows are aligned, there is sometimes very considerable force which is required to push up the cap away from the container, so as to remove the cap; and, sometimes, once again, that force is more than can be applied by an arthritic patient.
The question of whether a cap or closure for a pill container is child-resistant or child-proof or not is generally determined by the following criteria:
A child-resistant package must be such that, first, when it is tested by a group which comprises children, the child-resistant package cannot be opened by at least 85% of those children prior to a demonstration to them as to the proper means of opening the package; but still cannot be opened by at least 80% of those children after the demonstration to them of the proper means for opening the package. In the case where a child-resistant package is provided to a test group of adults, it must be capable of being opened by at least 90% of those adults; and, where the package is designed so that it may be re-closed, it can be re-closed by at least 90% of those adults but still cannot be opened by at least 85% of children to whom no demonstration as the proper method of opening the package has been given, nor by 80% of those children after a demonstration has been made.
The general format for pill containers is that they are cylindrical containers, which are not space efficient--in that it may not be easily stacked except in an end-to-end fashion, and even then only precariously. Moreover, placement of a number of cylindrical pill containers together results in an inefficient use of the volume in which they are placed due to the spaces left between the curved cylindrical walls. Still further, so as to read the directions for consumption of the prescribed mediation contained in a cylindrical pill container, the patient or caregiver must turn or rotate the cylindrical pill container to read all of the directions which are placed on a label which is adhesively affixed to the cylindrical pill container.
A particular disadvantage of prior art closures for pill containers, such as those described above, is that, when the cap or closure is removed from the pill container, it is then physically separated from the pill container. This may lead to loss of the closure, in some instances. Moreover, where the patient or caregiver is removing a number of pills from different pill containers to be consumed by the patient at one time, there is a risk that the wrong cap or closure will be put back on any given pill container.
Still further, there is also a risk with cylindrical pill containers in general that children may place the cap in their mouth. In the case where the cap is loose, this might result in choking. In the case where the cap is in place on the pill container, it could result in an advertent opening of the pill container.
If an open cylindrical pill container is dropped or upset, there is a significant risk that all of the remaining pills in the container will be spilled out of it. As will be described hereafter, one of the purposes of the present invention is to minimize that risk.